Prothena Corporation plc
Prothena Corp plc (Form: 8-K, Received: 05/08/2018 16:33:38)


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________________________________________
FORM 8-K  
_______________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 8, 2018
_______________________________________________________
PROTHENA CORPORATION PUBLIC LIMITED COMPANY
(Exact Name of Registrant as Specified in its Charter)
_______________________________________________________
 
 
 
 
 
Ireland
 
001-35676
 
98-1111119
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
 
 
Adelphi Plaza
Upper George's Street
Dún Laoghaire
Co. Dublin, A96 T927, Ireland
(Address of principal executive offices including Zip Code)
Registrant’s telephone number, including area code: 011-353-1-236-2500
(Former Name or Former Address, if Changed Since Last Report.)  
_______________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o





Item 2.02.
Results of Operations and Financial Condition.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically incorporate by reference the information furnished pursuant to Item 2.02 (including Exhibit 99.1) of this Current Report.
On May 8, 2018 , Prothena Corporation plc issued a press release announcing its financial results for the first quarter ended March 31, 2018 . A copy of that press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01.
Financial Statements and Exhibits
(d)  Exhibits .
 
 
 
Exhibit No.
 
Description
99.1
 


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:
May 8, 2018
PROTHENA CORPORATION PLC
 
 
 
 
 
 
 
By:
 
/s/ Tran B. Nguyen
 
 
Name:
 
Tran B. Nguyen
 
 
Title:
 
Chief Financial Officer





Exhibit 99.1
                                                
PROTHENARGBFULLCOLOR.JPG
Prothena Reports First Quarter 2018 Financial Results and Provides R&D Update
Net cash used in operating and investing activities was $31.8 million in the first quarter; quarter-end cash and restricted cash position of $433.1 million supports advancement through key milestones of R&D pipeline
Entered into global neuroscience research & development collaboration with Celgene to advance novel therapies for patients with neurodegenerative diseases
Initiated a first-in-human study of PRX004 in patients with ATTR amyloidosis

DUBLIN, Ireland - May 8, 2018 - Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan categories, today reported financial results for the first quarter of 2018. In addition, the Company provided an update on its R&D programs.

“We are moving several programs in our clinical and discovery pipeline forward and have recently initiated a Phase 1 study of PRX004 in patients with ATTR amyloidosis,” said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “Through our recently announced neuroscience R&D collaboration with Celgene, we are advancing three discovery programs that target a broad range of neurodegenerative diseases. While we recently discontinued development of NEOD001, we remain focused on pursuing new and better treatment options for patients through a scientifically rigorous approach in our research and development efforts.”

First Quarter 2018 and Recent Highlights:

Entered into a global neuroscience research & development collaboration with Celgene Corporation to develop new therapies for a broad range of neurodegenerative diseases. The collaboration is focused on three targets implicated in the pathogenesis of several neurodegenerative diseases, inducing tau, TDP-43 and a third that is undisclosed. Prothena received a $100 million upfront payment and a $50 million equity investment by Celgene and is eligible to receive future potential exercise payments and regulatory and commercial milestones for each licensed program. Prothena is also eligible to receive additional royalties on net sales of any resulting marketed products.
Presented a broad range of scientific and health outcomes data in oral and poster presentations at the 16 th International Symposium on Amyloidosis (ISA). New research was presented at ISA relating to PRX004 for the potential treatment of ATTR amyloidosis, including a proprietary mis-TTR assay developed to measure the misfolded forms of transthyretin (TTR) protein present in plasma of patients with hereditary ATTR amyloidosis, as well as preclinical research demonstrating that conformation-specific antibodies target misfolded TTR and induce immune mediated clearance through phagocytosis.
Announced the discontinuation of development of NEOD001, an investigational antibody that was being evaluated for the treatment of AL amyloidosis. The decision was based on results from the Phase 2b PRONTO study and a futility analysis of the Phase 3 VITAL study.





Achieved first-in-human dosing in a Phase 1 clinical study of PRX004 in patients with ATTR amyloidosis. PRX004 is an investigational antibody designed to target and clear the pathogenic, misfolded forms of the TTR protein found in ATTR amyloidosis without affecting the native, or normal tetrameric form of the protein. The Phase 1 study will evaluate PRX004 in patients with ATTR amyloidosis to inform possible future studies and will include the use of Prothena’s propriety mis-TTR assay as a pharmacodynamic measure of the levels of misfolded TTR species in plasma across multiple hereditary TTR mutations.

Upcoming Research and Development Milestones

PRX002/RG7935
The Phase 2 PASADENA study, initiated in the second quarter of 2017, continues to enroll patients with early Parkinson's disease
PRX004
The Phase 1 study of PRX004, initiated in the second quarter of 2018, continues to enroll patients with ATTR amyloidosis, and preliminary data from this study is expected in 2019

First Quarter 2018 Financial Results and Updated 2018 Financial Guidance
Prothena reported a net loss of $48.7 million for the first quarter of 2018, as compared to a net loss of $35.4 million for the first quarter of 2017. Net loss per share for the first quarter of 2018 was $1.26 , as compared to a net loss per share of $0.99 for the first quarter of 2017.
Prothena reported total revenue of $0.2 million for the first quarter of 2018, as compared to total revenue of $0.3 million for the first quarter of 2017 from our collaboration with Roche.

Research and development (R&D) expenses totaled $34.7 million for the first quarter of 2018, as compared to $25.7 million for the first quarter of 2017. The increase in R&D expenses for the first quarter of 2018 compared to the same period in the prior year was primarily due to higher consulting expenses, higher personnel costs, higher expense associated with PRX002/RG7935 and to a lesser extent higher clinical trial costs partially offset by lower product manufacturing expenses. R&D expenses included non-cash share-based compensation expense of $2.3 million for the first quarter of 2018, as compared to $2.3 million for the first quarter of 2017.

General and administrative (G&A) expenses totaled $14.2 million for the first quarter of 2018, as compared to $10.8 million for the first quarter of 2017. The increase in G&A expenses for the first quarter of 2018 compared to the same period in the prior year was primarily due to higher personnel costs and to a lesser extent higher legal expense. G&A expenses included non-cash share-based compensation expense of $4.6 million in the first quarter of 2018, as compared to $3.3 million in the first quarter of 2017.

Total non-cash share-based compensation expense was $6.9 million for the first quarter of 2018, as compared to $5.6 million for the first quarter of 2017.

As of March 31, 2018 , Prothena had $433.1 million in cash, cash equivalents and restricted cash and no debt.

As of April 20, 2018 , Prothena had approximately 39.8 million ordinary shares outstanding.






With the recent discontinuation of the NEOD001 program, the Company is assessing its resources relative to its current pipeline and is developing a reorganization plan. It expects to provide an update during the second quarter on reorganization plans and financial guidance for 2018.

About Prothena
Prothena Corporation plc is a global clinical-stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan categories. Fueled by its deep scientific understanding built over decades of research in protein misfolding, Prothena seeks to fundamentally change the course of progressive, life-threatening diseases associated with this biology. Prothena is advancing a pipeline of antibody therapeutic candidates for a number of indications and novel targets including Parkinson's disease and other related synucleinopathies (PRX002/RG7935) and ATTR amyloidosis (PRX004), as well as tau, Aβ (Amyloid beta) and TDP-43 where its scientific understanding of disease pathology can be leveraged. For more information, please visit the Company's website at www.prothena.com and follow us @ProthenaCorp.

Forward-looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash to support advancement of our R&D pipeline through key milestones; our goal of moving several programs in our clinical and discovery pipeline forward, including those under our collaboration with Celgene; amounts we might receive under our collaboration with Celgene; our focus on pursuing new and better treatment options for patients; the design, proposed mechanism of action and potential therapeutic benefits of PRX004; the objective and design of the Phase 1 study of PRX004; the intended use of our proprietary assay as a pharmacodynamic measure across multiple hereditary TTR mutations; the expected timing of having data from the Phase 1 study of PRX004; the possibility of further studies of PRX004; enrollment in the Phase 2 study of PRX002; and our plan and timing to develop a reorganization plan and provide an update on that plan and financial guidance for 2018. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks, uncertainties and other factors described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2018 and our subsequent Quarterly Reports on Form 10-Q filed with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena's expectations.






PROTHENA CORPORATION PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)

 
 
Three Months Ended
March 31,
 
 
2018
 
2017
Collaboration revenue
 
$
227

 
$
259

Total revenue
 
227

 
259

Operating expenses:
 
 
 
 
Research and development
 
34,706

 
25,698

General and administrative
 
14,229

 
10,832

Total operating expenses
 
48,935

 
36,530

Loss from operations
 
(48,708
)
 
(36,271
)
Other expense, net
 
(72
)
 
(774
)
Loss before income taxes
 
(48,780
)
 
(37,045
)
Benefit from income taxes
 
(37
)
 
(1,661
)
Net loss
 
$
(48,743
)
 
$
(35,384
)
Basic and diluted net loss per share
 
$
(1.26
)
 
$
(0.99
)
Shares used to compute basic and diluted net loss per share
 
38,684

 
35,758







PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
 
March 31,
 
December 31,
 
2018
 
2017
Assets
 
 
 
Cash and cash equivalents
$
429,039

 
$
417,620

Accounts receivable
100,012

 
240

Other current assets
8,102

 
8,467

Total current assets
537,153

 
426,327

Property and equipment, net
54,278

 
54,990

Restricted cash
4,056

 
4,056

Other assets
11,160

 
10,956

Total non-current assets
69,494

 
70,002

Total assets
$
606,647

 
$
496,329

Liabilities and Shareholders’ Equity
 
 
 
Accrued research and development
$
15,693

 
$
13,509

Other current liabilities
19,862

 
23,862

Total current liabilities
35,555

 
37,371

Deferred revenue
110,242

 

Other non-current liabilities
51,345

 
51,769

     Total non-current liabilities
161,587

 
51,769

Total liabilities
197,142

 
89,140

Total shareholders’ equity
409,505

 
407,189

Total liabilities and shareholders’ equity
$
606,647

 
$
496,329



Media and Investor Contact:

Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com